DyskinesiaPhase 2/3EASEDNCT01397422
Extended Release Amantadine Safety and Efficacy Study in Levodopa-Induced Dyskinesia (EASED Study)
A Phase 2/3 study testing ADS-5102 (extended release amantadine HCl) in people with Dyskinesia and Levodopa Induced Dyskinesia, run by Adamas Pharmaceuticals, Inc. at 33 sites in United States.
Trial summary
This is a multi-center, randomized, double-blind, placebo-controlled, 4-arm parallel group study to evaluate the tolerability and efficacy of each of three dose levels of ADS-5102 oral capsules, an extended release formulation of amantadine, dosed once daily for the treatment of levodopa-induced dyskinesia (LID) in… Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Dyskinesia, Levodopa Induced Dyskinesia, Parkinson's Disease
- What is being tested?
- ADS-5102 (extended release amantadine HCl)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 83 participants
- Where
- 33 sitesUnited States
- Study dates
- Jul 2011to Oct 2013
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed a current IRB/IEC-approved informed consent form
- Parkinson's disease, per UK Parkinson's Disease Society (UKPDS) Brain Bank Clinical Diagnostic Criteria
- On a stable regimen of antiparkinson's medications , including any levodopa preparation administered not less than three times daily, and willing to continue the same doses and regimens during study participation
- Experiencing troublesome dyskinesia following levodopa dosing (peak dose dyskinesia)
- Able to understand and complete a standardized PD home diary, following training
Who cannot join
- History of neurosurgical intervention related to Parkinson's disease (e.g. deep brain stimulation)
- History of seizures or stroke/TIA within 2 years of screening
- History of cancer within 5 years of screening, except adequately treated non-melanomatous skin cancers, localized bladder cancer, non-metastatic prostate cancer or in situ cervical cancer
- Estimated GFR < 50 mL/min/1.73m2
- Presence of cognitive impairment, as evidenced by a Mini-Mental Status Examination (MMSE) score of less than 24 during screening
- If female, is pregnant or lactating, or has a positive pregnancy test result pre-dose
Show all 9Show fewer
- If a sexually active female, is not surgically sterile or at least 2 years post-menopausal, or does not agree to utilize an effective method of contraception from screening through at least 4 weeks after the completion of study treatment
- Treatment with an investigational drug or device within 30 days prior to screening
- Treatment with an investigational biologic within 6 months prior to screening
Trial locations and contacts
33 sites in 1 country.
33 sites in 1 country
United States33 sites
Study site
Atlanta, Georgia
Study site
Augusta, Georgia
Study site
Boca Raton, Florida
Study site
Boston, Massachusetts
Study site
Bradenton, Florida
Study site
Chicago, Illinois
Study site
Des Moines, Iowa
Study site
Durham, North Carolina
Study site
Fairfield, Connecticut
Study site
Fountain Valley, California
Study site
Houston, Texas
Study site
Kansas City, Kansas
Study site
Kirkland, Washington
Study site
Long Beach, California
Study site
Los Angeles, California
Study site
Milwaukee, Wisconsin
Study site
New York, New York
Study site
Oxnard, California
Study site
Pasadena, California
Study site
Port Charlotte, Florida
Study site
Raleigh, North Carolina
Study site
Reseda, California
Study site
Richmond, Virginia
Study site
San Antonio, Texas
Study site
Sun City, Arizona
Study site
Sunnyvale, California
Study site
Tampa, Florida
Study site
Toledo, Ohio
Study site
Toms River, New Jersey
Study site
Tulsa, Oklahoma
Study site
Ventura, California
Study site
West Bloomfield, Michigan
Study site
Winfield, Illinois
About this study
This is a multi-center, randomized, double-blind, placebo-controlled, 4-arm parallel group study to evaluate the tolerability and efficacy of each of three dose levels of ADS-5102 oral capsules, an extended release formulation of amantadine, dosed once daily for the treatment of levodopa-induced dyskinesia (LID) in subjects with Parkinson's disease (PD). The novel pharmacokinetic profile of ADS-5102 is expected to achieve i) higher amantadine plasma concentrations during daytime hours when dyskinesia as well as motor and non-motor symptoms of PD are most problematic, ii) low amantadine plasma concentrations overnight, which may reduce the sleep disturbances and vivid dreams occasionally associated with amantadine, and iii) a reduced initial rate of rise in plasma concentration, which is expected to improve overall tolerability of amantadine.
- Conditions
- Dyskinesia, Levodopa Induced Dyskinesia, Parkinson's Disease
- Being tested
- ADS-5102 (extended release amantadine HCl)
- Keywords
- Levodopa-induced dyskinesia, Parkinsonism
- Medical subject headings
- Dyskinesias, Parkinson Disease, Parkinsonian Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADS-5102 (extended release amantadine HCl)Drug
Oral capsules to be administered once daily at bedtime, for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Placebo comparator | Not described Receives: Drug: ADS-5102 (extended release amantadine HCl) |
| Treatment B | Active comparator | Low dose ADS-5102 (amantadine extended release) Receives: Drug: ADS-5102 (extended release amantadine HCl) |
| Treatment C | Active comparator | A mid-dose ADS-5102 (amantadine extended release) Receives: Drug: ADS-5102 (extended release amantadine HCl) |
| Treatment D | Active comparator | High dose ADS-5102 (amantadine extended release) Receives: Drug: ADS-5102 (extended release amantadine HCl) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Unified Dyskinesia Rating Scale (UDysRS) Total Score From Baseline to Week 8
The UDysRS is a dyskinesia rating scale from 0-104, and it evaluates involuntary movements associated with PD. A higher score indicates more severe PD. The last observation carried forward (LOCF) method was used for analysis. Participants were summarized according to the actual treatment received.
Measured: Baseline (Day 1) and Week 8
Secondary outcomes (5)
Change in the Fatigue Severity Score (FSS) From Baseline to Week 8
The FSS is a 9-item self-reported scale, rating subject experience of fatigue during the previous 7 days. The total score, on a scale from 1-7, is represented by the mean of all answered items. The higher the score, the greater the fatigue severity.
Measured: Baseline (Day 1) and Week 8
Change in Total Objective Score (III, IV) of the UDysRS From Baseline to Week 8
UDysRS Part III measures objective impairment (dyskinesia severity, anatomic distribution, and type, based on 4 observed activities); and Part IV measures objective disability based on Part III activities. The scores for the 2 Parts combined range from 0-44; a higher score represents more severe dyskinesia.
Measured: Baseline (Day 1) and Week 8
Change in ON Time Without Troublesome Dyskinesia (ON Without Dyskinesia Plus ON With Non-troublesome Dyskinesia) From Baseline to Week 8; Based on a Standardized PD Home Diary
A PD home diary was used to score 5 different conditions in 30-minute time intervals: ASLEEP, OFF, ON (ie, had adequate control of PD symptoms) without dyskinesia, ON with non-troublesome dyskinesia, and ON with troublesome dyskinesia. The results were based on 2 consecutive 24-hour diaries taken prior to the day of randomization and prior to the Week 8 visit.
Measured: Baseline (Day 1) and Week 8
Change in Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Combined Scores (Parts I, II, III) From Baseline to Week 8
The MDS-UPDRS Parts I, II, and III examined non-motor experiences of daily living, motor experiences of daily living, and motor examination, respectively. Each part had sub scales ranging from normal = 0 to severe = 4.
Measured: Baseline (Day 1) and Week 8
Clinician's Global Impression of Change (CGI-C) in Overall PD Symptoms From Baseline to Week 8
The CGI-C consisted of a single question that assessed the investigator's global impression of the subject's change from Baseline in overall PD symptoms, including but not limited to LID. The CGI-C required that the investigator rate the extent to which the subject's PD had improved or worsened (from marked worsening to marked improvement).
Measured: Baseline (Day 1) and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionMay 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DyskinesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adamas Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials Director, Study director, Adamas Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01397422
- Sponsor's protocol ID
- ADS-PAR-AM201
- Acronym
- EASED
- Status last verified
- Nov 2017
- First submitted
- 18 Jul 2011
- Last updated
- 13 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extended Release Amantadine Safety and Efficacy Study in Levodopa-Induced Dyskinesia (EASED Study)
- ClinicalTrials.gov ID
- NCT01397422
- Acronym / sponsor ID
- EASED / ADS-PAR-AM201
- Conditions
- Dyskinesia, Levodopa Induced Dyskinesia, Parkinson's Disease
- Keywords
- Levodopa-induced dyskinesia, Parkinsonism
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Adamas Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- May 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 19 Jul 2011 (estimated)
- Results
- Posted 6 Nov 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multi-center, randomized, double-blind, placebo-controlled, 4-arm parallel group study to evaluate the tolerability and efficacy of each of three dose levels of ADS-5102 oral capsules, an extended release formulation of amantadine, dosed once daily for the treatment of levodopa-induced dyskinesia (LID) in subjects with Parkinson's disease (PD). The novel pharmacokinetic profile of ADS-5102 is expected to achieve i) higher amantadine plasma concentrations during daytime hours when dyskinesia as well as motor and non-motor symptoms of PD are most problematic, ii) low amantadine plasma concentrations overnight, which may reduce the sleep disturbances and vivid dreams occasionally associated with amantadine, and iii) a reduced initial rate of rise in plasma concentration, which is expected to improve overall tolerability of amantadine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Placebo comparator | Drug: ADS-5102 (extended release amantadine HCl) |
| Treatment B | Active comparator | Drug: ADS-5102 (extended release amantadine HCl)Low dose ADS-5102 (amantadine extended release) |
| Treatment C | Active comparator | Drug: ADS-5102 (extended release amantadine HCl)A mid-dose ADS-5102 (amantadine extended release) |
| Treatment D | Active comparator | Drug: ADS-5102 (extended release amantadine HCl)High dose ADS-5102 (amantadine extended release) |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Signed a current IRB/IEC-approved informed consent form
- Parkinson's disease, per UK Parkinson's Disease Society (UKPDS) Brain Bank Clinical Diagnostic Criteria
- On a stable regimen of antiparkinson's medications , including any levodopa preparation administered not less than three times daily, and willing to continue the same doses and regimens during study participation
- Experiencing troublesome dyskinesia following levodopa dosing (peak dose dyskinesia)
- Able to understand and complete a standardized PD home diary, following training
Key exclusion criteria (9 listed)
- History of neurosurgical intervention related to Parkinson's disease (e.g. deep brain stimulation)
- History of seizures or stroke/TIA within 2 years of screening
- History of cancer within 5 years of screening, except adequately treated non-melanomatous skin cancers, localized bladder cancer, non-metastatic prostate cancer or in situ cervical cancer
- Estimated GFR < 50 mL/min/1.73m2
- Presence of cognitive impairment, as evidenced by a Mini-Mental Status Examination (MMSE) score of less than 24 during screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ADS-5102 (extended release amantadine HCl)Oral capsules to be administered once daily at bedtime, for 8 weeks | Drug | Treatment A, Treatment B, Treatment C, Treatment D |
Primary outcome
Change in the Unified Dyskinesia Rating Scale (UDysRS) Total Score From Baseline to Week 8
Time frame: Baseline (Day 1) and Week 8
The UDysRS is a dyskinesia rating scale from 0-104, and it evaluates involuntary movements associated with PD. A higher score indicates more severe PD. The last observation carried forward (LOCF) method was used for analysis. Participants were summarized according to the actual treatment received.
5 secondary outcomes
Change in the Fatigue Severity Score (FSS) From Baseline to Week 8
Time frame: Baseline (Day 1) and Week 8
Change in Total Objective Score (III, IV) of the UDysRS From Baseline to Week 8
Time frame: Baseline (Day 1) and Week 8
Change in ON Time Without Troublesome Dyskinesia (ON Without Dyskinesia Plus ON With Non-troublesome Dyskinesia) From Baseline to Week 8; Based on a Standardized PD Home Diary
Time frame: Baseline (Day 1) and Week 8
Change in Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Combined Scores (Parts I, II, III) From Baseline to Week 8
Time frame: Baseline (Day 1) and Week 8
Clinician's Global Impression of Change (CGI-C) in Overall PD Symptoms From Baseline to Week 8
Time frame: Baseline (Day 1) and Week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Dyskinesia
RecruitingObservational study
Distinguishing Tics and Functional Tics Using Clinical Neurophysiological Techniques
Tics, Functional Tics
RecruitingPhase 2/3
Study to Evaluate the Pharmacodynamics, Safety and Efficacy of SKY-0515 in Participants With Huntington's Disease
Huntington Disease
RecruitingPhase 1
A Study of SGT-212 Gene Therapy in Friedreich's Ataxia
Friedreich's Ataxia (FA)
RecruitingPhase 3
Nabilone for Agitation Blinded Intervention Trial
Alzheimer Disease, Agitation
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials Director study director
Adamas Pharmaceuticals, Inc.
33 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing ADS-5102 (extended release amantadine HCl) in people with Dyskinesia and Levodopa Induced Dyskinesia, run by Adamas Pharmaceuticals, Inc. at 33 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Nov 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Unified Dyskinesia Rating Scale (UDysRS) Total Score From Baseline to Week 8 (time frame: Baseline (Day 1) and Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2017.